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• W2897053047 abstract "To evaluate the safety and efficacy of preoperative chemoradiation and D2 radical resection in patients with locally advanced gastroesophageal junction carcinoma. Gastroesophageal junction carcinoma patients with adenocarcinoma, clinical stage T3-4N0 or any TN1-3M0, Siewert type II and III were enrolled. After exclusion of peritoneal metastasis with laparoscopic exploration, patients were randomly assigned into surgery group and preoperative chemoradiation plus surgery group. The preoperative chemoradiation group received intensity modulated radiation therapy (IMRT) and concurrent chemotherapy S-1 combined with oxaliplatin weekly plan. The prescription dose was GTV 50Gy/CTV 45Gy/25f/35d with concomitant boost. For the concurrent chemotherapy, S-1 was 30mg/m2 bid, five days a week; oxaliplatin was 40mg/m2 per week, with a total of 5 weeks. Laparoscopic exploration was needed 6 weeks after the end of the preoperative chemoradiation. Patients with no peritoneal metastasis underwent D2 radical resection. Postoperative patients received SOX chemotherapy for 6-8 cycles. This trial (PAPER) is a multicenter randomized controlled study. Primary endpoint is 2-year DFS, the secondary end points are safety and effectivity. From Sep. 2014 to Sep. 2017, 90 cases of 5 centers were enrolled. There were 45 patients in surgery group and 45 cases in the preoperative chemoradiation group. In the preoperative chemoradiation group, all patients completed radiation therapy. Five patients cannot tolerate full course concurrent chemotherapy due to toxicities. There was no grade 4 toxicity. The incidence of grade 3 toxicities was 11.1% (5/45): neutropenia. The incidences of grade 2 toxicities were 46.7% (21/45), mainly including: thrombocytopenia (26.7%), neutropenia (6.7%), esophagitis and nausea (13.3%). Thirty-one patients underwent radical D2 resection. Fourteen patients are waiting for resection. Pathological complete response occurred in 16.1% (5/31) of patients. The T and N downstaging rate were 83.9% (26/31) and 80.6% (25/31), respectively. The tumor regression grade (TRG) were 5 cases of Grade 0, 11 cases of Grade 1 and 12 cases of Grade 2 and 3 cases of Grade 3, respectively. Surgery-related complications consisted of anastomotic leakage in 3 (9.7%), infection in 2 (6.4%), and hemorrhage in 1 (3.2%) patients. The perioperative mortality was nil. Among 45 patients of the surgery group, surgery-related complications consisted of anastomotic leakage in 3 (9.7%), infection in 3 (9.7%), and hemorrhage in 2 (6.4%) patients. The perioperative mortality was nil. Postoperative complications had no significant differences between two groups. Preoperative chemoradiation for patients with locally advanced gastroesophageal junction adenocarcinoma showed an acceptable toxicity, promising efficacy and safety for D2 resection. Further conclusions need to be verified by the last results of multicenter data." @default.
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• W2897053047 date "2018-11-01" @default.
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• W2897053047 title "Safety and Efficacy of Preoperative Chemoradiotherapy in Patients with Locally Advanced Gastroesophageal Junction Carcinoma: The Multicenter Randomized PAPER Trial in China" @default.
• W2897053047 doi "https://doi.org/10.1016/j.ijrobp.2018.07.053" @default.
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